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Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced

Primary Purpose

Neoplasms, Anemia

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Darbepoetin alfa (Aranesp®)
Ferric saccharose(Venofer®)
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neoplasms focused on measuring Neoplasms, Solid, Anemia, darbepoetin alfa, ferric saccharose, Venofer®, Aranesp®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years Well-informed written consent, signed by the patient Patient picked up for solid tumor treatment, whichever the localization, with or without metastasis Patient revealing, before or during chemotherapy, a moderate anemia, that means: Men: 9<Hb<12 g/dl; Women: 9<Hb<11 g/dl. Patient for who at least four chemotherapy cycles are planed (eight in case of weekly chemotherapy) after inclusion in the study Patients with life expectancy higher than three months Patient with general conditions compatible with the study's follow-up Exclusion Criteria: Contra-indication for Venofer Anemia which can have curative treatment Bloody transfusion during the previous four weeks Documented or suspected medullary invasion Uncontrolled arterial hypertension Acute bacterial infection Transferrin saturation's coefficient Pregnancy Ferric salts oral treatment interrupted since less than one week Patient with bad french language's comprehension Patient with a major psychiatric pathology Patient under guardianship, trusteeship or justice safeguard

Sites / Locations

  • Centre Hospitalier de Castres
  • Centre Hospitalier de Montauban
  • Centre Hospitalier Joseph Ducuing
  • Institut Claudius Regaud

Outcomes

Primary Outcome Measures

Biological response rate for each group.

Secondary Outcome Measures

To determine tolerance for ferric saccharose (Venofer®)
To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®)
To determine percentage of hemoglobin rate's correction
To determine biological parameters's evolution

Full Information

First Posted
September 12, 2005
Last Updated
November 13, 2006
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT00210002
Brief Title
Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
Official Title
Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Terminated
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institut Claudius Regaud

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Anemia
Keywords
Neoplasms, Solid, Anemia, darbepoetin alfa, ferric saccharose, Venofer®, Aranesp®

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa (Aranesp®)
Intervention Type
Drug
Intervention Name(s)
Ferric saccharose(Venofer®)
Primary Outcome Measure Information:
Title
Biological response rate for each group.
Secondary Outcome Measure Information:
Title
To determine tolerance for ferric saccharose (Venofer®)
Title
To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®)
Title
To determine percentage of hemoglobin rate's correction
Title
To determine biological parameters's evolution

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Well-informed written consent, signed by the patient Patient picked up for solid tumor treatment, whichever the localization, with or without metastasis Patient revealing, before or during chemotherapy, a moderate anemia, that means: Men: 9<Hb<12 g/dl; Women: 9<Hb<11 g/dl. Patient for who at least four chemotherapy cycles are planed (eight in case of weekly chemotherapy) after inclusion in the study Patients with life expectancy higher than three months Patient with general conditions compatible with the study's follow-up Exclusion Criteria: Contra-indication for Venofer Anemia which can have curative treatment Bloody transfusion during the previous four weeks Documented or suspected medullary invasion Uncontrolled arterial hypertension Acute bacterial infection Transferrin saturation's coefficient Pregnancy Ferric salts oral treatment interrupted since less than one week Patient with bad french language's comprehension Patient with a major psychiatric pathology Patient under guardianship, trusteeship or justice safeguard
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Dugat, Pr
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Castres
City
Castres
Country
France
Facility Name
Centre Hospitalier de Montauban
City
Montauban
Country
France
Facility Name
Centre Hospitalier Joseph Ducuing
City
Toulouse
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced

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